MastectomyNCT01176786
Reusable Versus Disposable Draping System in Breast Reconstruction Surgery
A study testing Culture Swabs, Rodac Plate Cultures in people with Mastectomy and Infections, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Infections, Breast Reconstruction
- What is being tested?
- Culture Swabs, Rodac Plate Cultures
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ages 18 years of age and older who are having a mastectomy with tissue expander placement and for breast implants for reconstruction, which would include immediate or delayed reconstruction.
Who cannot join
- Male subjects are excluded from this study, while some males do have breast cancer, this is a rare occurrence and they do not undergo reconstruction surgery with expanders and breast implants. Females under the age of 18 are excluded as well as females who undergo a mastectomy but do not have any reconstruction surgery. Females who otherwise meet the criteria but have an active infection, currently on antibiotics to treat an infection, urinary tract infections, soft tissue infections or pneumonia are also excluded until they are approved for surgery by the physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center Plastic & Reconstructive Surgery Department
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effect of Reusable Versus Disposable Draping on Implant Based Breast Reconstruction Infection Rates: a Prospective Randomized Study
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.
Read the detailed description
Subjects enrolled in the study will be randomized into two groups. One group will have the reusable draping system during surgery which the investigators currently use and the second group will have the disposable draping system. Subjects will be blinded to the type of draping system used. Subjects are under anesthesia at the time the surgical drapes are placed. After the subject has signed the informed consent, they will be assigned a study number for that surgery. The study number will correlate to an envelope which will contain information on the type of draping system to be used. Subjects enrolled, may be randomized more than once. Subjects will typically have a minimum of two surgeries, the placement of the tissue expanders and then the removal of the expanders and placement of the breast implants. Subjects will not be required to sign another consent form but will be randomized prior to each surgery. Surgeons who have subjects in the disposable draping system will use a disposable draping kit that includes gowns for the surgeons and also towels. For subjects who are having a mastectomy and then the placement of tissue expanders, after the mastectomy has been performed, the plastic surgeons will use all new draping, towels and gowns to perform tissue expander placement. A swab will be taken on the wound site to determine if there are any CFUs (colony forming units) present. The swab will then be placed in a tube containing 1ml of TSB (triptic soy broth). The tube will then be sonicated , and then vortexed for 15 seconds. A 0.1ml aliquot of the solution will be placed in a blood agar plate and incubated for 48 hours to determine the CFU count. The remainder of the solution will be frozen. In the event an infection occurs, molecular matching will be done on the culture to determine if it is from the same exact culture. Rodac plates will be used to test for the presence of bacterial cultures on the surgeon's gown (Forearm [volar surface]) and glove (palm of surgeon's dominate hand) and also the subject's surgical drape (Area over sternum). These will be incubated for 48 hours to determine the CFU count. This process will be repeated at the second surgery.
- Conditions
- Mastectomy, Infections, Breast Reconstruction
- Being tested
- Culture Swabs, Rodac Plate Cultures
- Keywords
- infection, tissue expander, breast implant, breast reconstruction, Infections rates
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture Swabs, Rodac Plate CulturesOther
Culture swab is taken when breast tissue expander is removed and when breast implant is placed in breast pocket. Rodac Plate cultures are taken after the surgical procedure of the surgeons dominant palm, forearm of gown and subject's drape closest to the breast.
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rates of reusable versus disposable draping system in the operating room
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa David, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176786
- Sponsor's protocol ID
- 10667
- Status last verified
- Jun 2017
- First submitted
- 5 Aug 2010
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reusable Versus Disposable Draping on Implant Based Breast Reconstruction Infection Rates: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01176786
- Acronym / sponsor ID
- 10667
- Conditions
- Mastectomy, Infections, Breast Reconstruction
- Keywords
- infection, tissue expander, breast implant, breast reconstruction, Infections rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the rate of infections developed by subjects comparing the use of disposable draping systems versus reusable draping systems in the operating room.
Detailed description
Subjects enrolled in the study will be randomized into two groups. One group will have the reusable draping system during surgery which the investigators currently use and the second group will have the disposable draping system. Subjects will be blinded to the type of draping system used. Subjects are under anesthesia at the time the surgical drapes are placed. After the subject has signed the informed consent, they will be assigned a study number for that surgery. The study number will correlate to an envelope which will contain information on the type of draping system to be used. Subjects enrolled, may be randomized more than once. Subjects will typically have a minimum of two surgeries, the placement of the tissue expanders and then the removal of the expanders and placement of the breast implants. Subjects will not be required to sign another consent form but will be randomized prior to each surgery. Surgeons who have subjects in the disposable draping system will use a disposable draping kit that includes gowns for the surgeons and also towels. For subjects who are having a mastectomy and then the placement of tissue expanders, after the mastectomy has been performed, the plastic surgeons will use all new draping, towels and gowns to perform tissue expander placement. A swab will be taken on the wound site to determine if there are any CFUs (colony forming units) present. The swab will then be placed in a tube containing 1ml of TSB (triptic soy broth). The tube will then be sonicated , and then vortexed for 15 seconds. A 0.1ml aliquot of the solution will be placed in a blood agar plate and incubated for 48 hours to determine the CFU count. The remainder of the solution will be frozen. In the event an infection occurs, molecular matching will be done on the culture to determine if it is from the same exact culture. Rodac plates will be used to test for the presence of bacterial cultures on the surgeon's gown (Forearm [volar surface]) and glove (palm of surgeon's dominate hand) and also the subject's surgical drape (Area over sternum). These will be incubated for 48 hours to determine the CFU count. This process will be repeated at the second surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females ages 18 years of age and older who are having a mastectomy with tissue expander placement and for breast implants for reconstruction, which would include immediate or delayed reconstruction.
Key exclusion criteria (1 listed)
- Male subjects are excluded from this study, while some males do have breast cancer, this is a rare occurrence and they do not undergo reconstruction surgery with expanders and breast implants. Females under the age of 18 are excluded as well as females who undergo a mastectomy but do not have any reconstruction surgery. Females who otherwise meet the criteria but have an active infection, currently on antibiotics to treat an infection, urinary tract infections, soft tissue infections or pneumonia are also excluded until they are approved for surgery by the physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culture Swabs, Rodac Plate CulturesCulture swab is taken when breast tissue expander is removed and when breast implant is placed in breast pocket. Rodac Plate cultures are taken after the surgical procedure of the surgeons dominant palm, forearm of gown and subject's drape closest to the breast. | Other | – |
Primary outcome
Infection rates of reusable versus disposable draping system in the operating room
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa David principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culture Swabs, Rodac Plate Cultures in people with Mastectomy and Infections, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rates of reusable versus disposable draping system in the operating room (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.